510(k) K241372
K241372 is an FDA 510(k) premarket notification submitted by ABBOTT MEDICAL for the device "Advisor HD Grid X Mapping Catheter, Sensor Enabled". The FDA issued a decision of Substantially Equivalent on July 9, 2024. The device falls under product code MTD (Catheter, Intracardiac Mapping, High-Density Array), a Class II device regulated under 21 CFR 870.1220. ABBOTT MEDICAL has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 9, 2024
- Date Received
- May 15, 2024
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Intracardiac Mapping, High-Density Array
- Device Class
- Class II
- Regulation Number
- 870.1220
- Review Panel
- CV
- Submission Type